Galderma Submits New QI Act 30-Month Stay Citizen Petition; a New Variation on an Old Theme

By Kurt R. Karst –      

Galderma Laboratories L.P. (“Galderma”) recently submitted a citizen petition to FDA (also see our Citizen Petition Tracker) requesting that the Agency interpret the QI Program Supplemental Funding Act of 2008 (“QI Act”) to impose a 30-month stay of approval of an ANDA referencing an old antibiotic drug product if that ANDA contains a Paragraph IV certification to a patent that was listed in the Orange Book in accordance with § 4(b)(1) of the QI Act.  The QI Act was enacted on October 8, 2008 and amended the FDC Act to add new § 505(v) – “Antibiotic Drugs Submitted Before November 21, 1997” – to create Hatch-Waxman benefits for so-called “old” antibiotics. 

Earlier this year, FDA received and responded to four citizen petitions arguing that a 30-month stay should apply.  Those petitions argued, among other things, that the plain language of the QI Act requires application of the 30-month stay provisions of the original Hatch-Waxman Amendments, rather than the version of the statute amended by the Medicare Modernization Act, which limits 30-month stays such that a generic applicant with a pending ANDA that amends its application to add a Paragraph IV certification to a later-listed patent is not subject to a 30-month stay in connection with that certification.  FDA determined that:

under the QI Act, no 30-month stay of approval will apply to an ANDA referencing an old antibiotic based on the grounds that the ANDA contains a paragraph IV certification to a later-listed patent and the NDA holder or patent owner has sued the ANDA applicant for patent infringement as a result of notice of the paragraph IV certification.  We note that, under current law, a 30-month stay will apply to an ANDA referencing an old antibiotic if that ANDA contains a paragraph IV certification to a patent submitted to the Agency before the ANDA was submitted, and the NDA holder or patent owner sues the ANDA applicant for patent infringement as a result of notice of the paragraph IV certification.

Galderma’s petition concerns the old antibiotic drug product ORACEA (doxycycline).  According to Galderma, Mylan submitted an ANDA to FDA containing a Paragraph IV certification to patents listed in the Orange Book for ORACEA in accordance with the QI Act, and Galderma timely sued Mylan for patent infringement.  (FDA’s Paragraph IV Certification List does not yet identify this ANDA submission.) 

Galderma states that its citizen petition is “entirely distinguishable” from the previous QI Act 30-month stay citizen petition submitted to FDA: “Unlike prior petitioners, Galderma does not contend that Congress, via the QI Act, directed FDA to apply the applicable statutory provisions of the original Hatch-Waxman Amendments as enacted in 1984, rather than as subsequently amended by Congress.”  Furthermore, Galderma states that the company “agrees with FDAs Denial Letter that ‘it is reasonable, both as a matter of statutory construction and sound public policy, to interpret section 505(v)(4) [of the QI Act] to require the application of the current law to old antibiotics . . . there is a strong argument that Congress intended this result.’” 

Indeed, according to Galderma, “this is precisely Galderma’s position – that Congress clearly intended to treat ‘old antibiotics’ consistent with ‘new antibiotics’ pursuant to current law, and that a single 30-month stay should apply to both classes of products.”  Galderma summarizes its argument as follows:

In sum, no previous petitioner argued, as this petitioner does, that the intent of Congress, embodied in the terms of the transition provisions of the QI Act, was to grant the opportunity to obtain both a single 30-month stay of ANDA approval and 180-day generic exclusivity to the holders of NDAs and ANDAs covered by the Q1 Act.  Although FDA addressed certain issues related to this petition in its recent Denial Letter, FDA has not directly addressed the issues raised herein as applicable to ORACEA.

It is unclear how fast FDA will act on this new petition.  FDA responded to the other four QI Act petitions witin several weeks of submission.